Relmada Therapeutics (RLMD) Q1 2026 earnings summary

Executive summary

• Reported robust 12-month Phase 2 data for NDV-01 in NMIBC, showing high complete response rates and durable efficacy, especially in BCG-unresponsive patients, with no progression to muscle-invasive disease or need for radical cystectomy.

• Completed $160 million private placement/PIPE financing, strengthening the balance sheet and providing funding runway through 2029, including phase III RESCUE program completion.

• Filed a provisional U.S. patent for NDV-01 in April 2026, potentially extending exclusivity to 2047 and enabling global filings.

• Preparing to initiate phase III RESCUE program for NDV-01 and a proof-of-concept/Phase 2b study for sepranolone in Prader-Willi syndrome, both targeted for mid-2026.

• Terminated esmethadone and psilocybin programs in 2025 after strategic review.

Financial highlights

• Ended Q1 2026 with $234 million in cash, cash equivalents, and short-term investments, up from $93 million at year-end 2025, reflecting $150 million in net proceeds from March private financing.

• Net loss for Q1 2026 was $19.1 million ($0.22 per share), compared to $17.6 million ($0.58 per share) in Q1 2025.

• Research and development expense decreased to $8.1 million from $12 million year-over-year, mainly due to non-recurrent prior year costs and program terminations.

• General and administrative expense rose to $11.4 million from $6.3 million year-over-year, mainly due to higher compensation and consulting costs.

• Net cash used in operating activities was $15.1 million, down from $18.1 million in Q1 2025.

Outlook and guidance

• On track to initiate phase III RESCUE program for NDV-01 and sepranolone Phase 2b study in Prader-Willi syndrome in mid-2026, with initial three-month NDV-01 Phase 3 data expected by year-end 2026.

• Current cash resources expected to fund operations through 2029, including completion of key clinical programs.

• Key milestones in 2026 include NDV-01 IND filing, Phase 3 trial initiations, and sepranolone Phase 2b start.